Kornimate/medical-research-clean huggingface dataset:
axos and microbial metabolites in ckd

Conditions: Chronic Kidney Disease

Summary: chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. evidence is mounting that the colonic microbiota contributes substantially to these uremic retention solutes. indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, overall mortality and chronic kidney disease progression. the most important regulator of colonic bacterial metabolism is nutrient availability and especially the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake of so-called prebiotics (non-digestible food ingredients). arabinoxylan oligosaccharides (axos) are a recently developed group of prebiotics, and already demonstrated a decreasing effect on intestinal generation of p-cresol in healthy individuals. whether prebiotics in general, and axos more specifically, can influence intestinal generation of microbial metabolites in predialysis patients has not been studied to date. an interventional study with axos will therefore be initiated to test the hypothesis that axos can decrease intestinal generation and serum concentrations of microbial metabolites in patients with ckd not yet on dialysis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 85 years * chronic kidney disease stage 3b-4, i.e., with estimated glomerular filtration rate (ckd-epi) between 45 - 15 ml/min/m² 29 * written informed consent exclusion criteria: * history of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy) * history of colonic surgery * recipient of a renal or other solid organ transplant * use of pre-/pro-/syn- or antibiotics in preceding 4 weeks
health literacy activation rct among the copd patients and designated support dyad

Conditions: COPD Exacerbation

Summary: this study investigates whether increasing health literacy among copd patients and their designated health coach during a hospital admission caused by symptoms exacerbation will lead to better health outcomes including increased health quality, and lower healthcare utilization.

until recently, contemporary methods to chronic disease management have failed to consistently tailor approaches among patients with low health literacy. they have produced mixed results in terms of successful interventions to address the needs of these populations. low health literacy is especially common in medically underserved communities, including in north philadelphia. this is reflected in the predominantly low-income and racial/ethnic minority population of the patients at this medical center. management of chronic conditions such as copd is complex. patients with low health literacy find it especially challenging to self-navigate disease management. however, there is a lack of information on approaches to improve health outcomes among copd patients with low health literacy. the long-term goal is to develop and evaluate a model of interventions to improve healthcare outcomes for socially disadvantaged populations. the objective is to pilot a randomized controlled trial that evaluates the effects of an intervention that provides enhanced education and material support, on adherence to care, among patients admitted for copd-related issues and their home support dyad. the central hypothesis is that: compared to the standard educational intervention delivered by a registered nurse, the addition of an enhanced intervention (enhanced education, problem-solving skills and facilitative support) and the inclusion of a patient-designated support pair will result in greater adherence care and improves quality of life, especially among patients with low health literacy.

Eligibility criteria:
inclusion criteria: * patients will be 55 years old and above * a history of hospital admissions for copd related issues * able to designate a support person that can help them manage their condition * discharged home exclusion criteria: * dyads unable to participate in the education session * patients discharged to a skilled nursing facility or rehabilitation facility.
annual study to investigate inactivated subunit influenza vaccine due to new virus strains for the 2010/2011 season

Conditions: Influenza

Summary: influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. in europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. the current study is a phase iiia clinical trial with a commercially available vaccine (influvac®) supplied in pre filled syringes. it is part of the ongoing clinical trial program for influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged \>= 18 and \ = 61 years of age (elderly)


Eligibility criteria:
inclusion criteria 1. willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. men and women aged \>= 18 and \ = 61 years of age at the day of study vaccination. 3. being in good health as judged by medical history, physical examination and clinical judgment of the investigator exclusion criteria 1. known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. 2. a serious adverse reaction after a previous (influenza) vaccination. 3. presence of any significant condition that may prohibit inclusion as determined by the investigator. 4. seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period. 5. a history of guillain-barré syndrome or active neurological disease

Keywords: influenza vaccine chmp criteria
study of the pharmacokinetics and safety of tasimelteon in children and adolescents

Conditions: Circadian Rhythm Sleep Disorders; Non-24 Hour Sleep-Wake Disorder; Autism Spectrum Disorder; Smith-Magenis Syndrome

Summary: open-label study to investigate the pharmacokinetics and safety of tasimelteon in children and adolescents.

this study is an open-label, single dose, non-controlled study to evaluate the pk and safety of tasimelteon in children and adolescents from 3 years to less than 18 years of age who were legally blind and met the diagnostic criteria for crswd non-24 per dsm-v or who were diagnosed with a neurodevelopmental disorder (like asd and sms) and had a nighttime sleep complaint.

Eligibility criteria:
inclusion criteria: 1. males or females 3 to \<18 years of age who are legally blind \[defined as having a visual acuity of 20/200 or less in the better-seeing eye with best conventional correction (glasses or contact lenses) and/or a visual field of 20 degrees or less in the better-seeing eye\], males or females 3 to \<18 years of age with sms and with a nighttime sleep complaint and males or females 3 to \<18 years of age with asd and with a nighttime sleep complaint; 2. weigh at least 10 kg; 3 diagnosis of sms determined by a prior positive genetic test result as indicated by parent/guardian; diagnosis of asd as indicated by parent/guardian; or a diagnosis of non-24 as determined by dsm-5 diagnostic criteria for the circadian rhythm sleep-wake disorder, non-24-hour sleep-wake hour type: 1. a persistent or recurrent pattern of sleep disruption that is primarily due to an alteration of the circadian system or to a misalignment between the endogenous circadian rhythm and the sleep-wake schedule required by an individual's physical environment or social or professional schedule; 2. the sleep disruption leads to excessive sleepiness or insomnia, or both; 3. the sleep disturbance causes clinically significant distress or impairment in social, occupational, and other important areas of functioning. exclusion criteria: 1. for blind subjects only: subjects who have a probable diagnosis of a current sleep disorder other than non-24-hour sleep-wake disorder that is the primary cause of the sleep disturbance based on clinical investigator medical judgment; 2. for blind subjects only: history (within the 12 months prior to screening) of psychiatric disorders including adhd, neurodisabilities, major depressive disorder, generalized anxiety disorder, axis ii disorders, delirium or any other psychiatric disorder, that is not being successfully treated or has not been resolved and that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures; 3. history of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
adequacy of anaesthesia for colonoscopic procedures

Conditions: Colonic Diseases, Functional

Summary: the aim of this randomized prospective trial is to assess the utility of adequacy of anaesthesia technique (response entropy and surgical pleth index) for monitoring pain perception intraoperatively and its influence on postoperative pain perception, both patients' and operators' satisfaction in patients undergoing colonoscopic procedures under intravenous sedation using propofol and fentanyl.

surgical pleth index (spi) is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures, where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level; values near 50 or increase in value \> delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia. the applicability of spi- guided deep sedation regimen in colonoscopic procedures has not been previously studied. additionally, depth of sedation markedly influences the nociception-antinociception balance so its monitoring also proved useful in procedures performed under deep sedation. therefore, we aim to investigate if both spi-guided fentanyl administration alongside with state entropy guided propofol aministration (adequacy of anaesthesia monitoring) versus state entropy guided propofol aministration alongside with fentanyl titration based on haemodynamic parametres versus fentanyl titration based on haemodynamic parametres only influence both patients' or operator's satisfaction from anaesthetic management.

Eligibility criteria:
inclusion criteria: * written consent to participate in the study * written consent to undergo deep sedation for colonoscopic procedure * general heath condition i-iii of american society of anaesthesiology exclusion criteria: * necessity of administration of vasoactive drugs influencing spi monitoring * pregnancy * anatomical malformation that make monitoring using se sensor impossible * general atherosclerosis, heart rhythm disturbances impairing spi monitoring * chronic medication using opioid drugs leading to resistancy to opioids.

Keywords: surgical pleth index (spi) adequacy of anaesthesia (aoa) state entropy (se) postoperative nausea and vomitting (ponv) colonoscopy
irreversible electroporation (nanoknife ®) and immunotherapy for the treatment of stage iv colorectal cancer

Conditions: Liver Metastasis Colon Cancer

Summary: the goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (ire) in patients with colon cancer that has spread to the liver (metastasis). the main questions it aims to answer are: 1. to document the rate of complications associated with combining ire with immune boosting drugs. 2. after one liver metastasis is treated with ire and immune boosting drugs, what is the change in the size of the non-ire-treated liver metastases? 3. what is the immune response (measured in a blood sample) when ire is combined with one or two types of immune boosting drugs?

single-centre pilot study of the use of ire for the treatment of 12 patients with unresectable colorectal liver metastases to assess feasibility and gain preliminary data to inform the design of a larger study.

Eligibility criteria:
inclusion criteria: 1. biopsy-proven colorectal liver metastases with at least one measuring \< 3.5 cm in diameter and accessible to percutaneous ire such that a complete ablation of the lesion is possible. 2. prior resection of the colorectal cancer primary. 3. the imaging has been reviewed in multi-disciplinary rounds and the colorectal liver metastases have been deemed unresectable. 4. patient has undergone chemotherapy and has not converted to resectable disease. 5. radiologic evidence of stable disease for at least two months on systemic therapy for colorectal cancer (may have had prior partial response or disease progression) 6. microsattelite instability (msi)-stable or mismatch-proficient tumors 7. patient has hla phenotype of human leukocyte antigen (hla) a1 or hla a2. 8. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. size of the metastasis being treated with ire \> 3.2 cm or \< 2 cm. 2. size of any non-ire-treated liver metastasis \> 4 cm 3. pregnancy 4. major comorbid disease 5. active autoimmune disease 6. bone or brain or peritoneal metastases. 7. msi high disease 8. patients with cardiac arrhythmia other than rate controlled atrial fibrillation. 9. metal implant that cannot be removed within 10 cm of the area to be treated. 10. peritoneal disease. 11. poor performance status 12. cirrhosis
toxicity attributed to genetic polymorphisms in testicular germ cell tumor survivors

Conditions: Germ Cell Cancer

Summary: the purpose of this study is to identify genetic variations in survivors of testicular cancer and connect these variations to differences in risks of late effects.

identification of late-effects through questionnaires and linkage to national registries. dna samples will be gathered through buccal swabs or saliva kits and analysed with whole exome-sequencing.

Eligibility criteria:
inclusion criteria: * danish citizen * diagnosed with germ cell cancer from 1984 to 2007 * treated initially at a danish hospital * treated with standard treatment regimens. exclusion criteria: * treated initially at a foreign hospital

Keywords: germ cell cancer late toxicity renal impairment cardiovascular disease
intracoronary thrombus assessed by ofdi after successful fibrinolysis and its impact on myocardial reperfusion

Conditions: Myocardial Infarction; Intracoronary Thrombus

Summary: the pharmacoinvasive approach after thrombolysis is the standard treatment of myocardial infarction when deadlines are too long for primary angioplasty. coronary angioplasty is then carried out within 3 to 24 hours following thrombolysis. the adjuvant antiplatelet therapy of thrombolysis combines aspirin with clopidogrel (75 or 300 mg depending on age). these clopidogrel doses are associated with a very low anti-platelet aggregation response within 24 hours following administration. however, the antiplatelet agregation that inhibits the progression of intracoronary thrombus must be optimal at the time of angioplasty to reduce the risk of thrombotic events. intracoronary thrombus residual angiographic post-thrombolysis was associated with impaired myocardial reperfusion but coronary angiography has a very low sensitivity for detecting the thrombus. the optical coherence tomography (oct) is currently the method of choice to visualize and quantify the intracoronary thrombus. it is used routinely in the presence of a thrombus to correctly estimate the size of the artery and for the evaluation of good stent apposition. the thrombectomy at the time of angioplasty improves myocardial reperfusion, particularly in case of major thrombotic mass. intracoronary thrombus residual post-thrombolysis could be a marker for the quality of reperfusion itself correlated to the quality of the antiplatelet post-thrombolysis. the investigators therefore hypothesize that the systematic use of the oct before elective angioplasty (within 3 to 24 hours) after successful thrombolysis could be used to guide the use of thrombectomy and adequate stenting and thus improve myocardial reperfusion. our study will also correlate the importance of the residual thrombus before angioplasty myocardial reperfusion one hand and to the inhibition of platelet activity observed other.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction * treated with successful fibrinolysis * who require coronary stenting exclusion criteria: * cardiogenic shock * hemostasis disorders * non accessible coronary lesion for oct * severe renal insuffisiency

Keywords: optimal coherence tomography myocardial reperfusion
an observational study of induction therapy with fuzeon (enfuvirtide) in combination with antiretroviral drugs in patients with hiv-1 infection

Conditions: HIV Infections

Summary: this multicenter, retrospective, observational study will evaluate the therapeutic effectiveness of a strategy of induction with fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with hiv-1 infection in routine clinical practice.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * hiv-1+ infection * patients with a viral load \> 50 copies/ml who have received induction treatment with fuzeon in combination with antiretroviral treatment * naïve for fuzeon at initiation of induction treatment * antiretroviral treatment of at least 12 months duration exclusion criteria: * patients who did not receive fuzeon treatment
electrical impulse parameters and neuronal population in the cochlear implanted patient-pulse

Conditions: Sensorineural Hearing Loss

Summary: the cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. modification of the coding strategies could improve these performances. a better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

the cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. modification of the coding strategies could improve these performances. currently, the intensity perceived by the patient is coded by the duration and the amplitude of the electrical impulse but companies have different approaches and fix one of the two parameters for the setting of the processors. a better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

Eligibility criteria:
inclusion criteria: * post-lingually deaf adults with at least one year of cochlear implant experience * unilateral and bilateral cochlear implant recipients * oticon device with neuro zti array * patient affiliated to french social security * consent signed exclusion criteria: * patients under court protection, guardianship or curatorship

Keywords: hearing loss cochlear implant psychoacoustic charge integration efficiency
developing a low-intensity primary care intervention for anxiety disorders (aim-pc)

Conditions: Anxiety Disorders

Summary: the purpose of the study is to develop a personalized, user-friendly computerized treatment for anxiety disorders linked to primary care. the computerized treatment is a type of cognitive bias modification, which targets attention and interpretation biases known to maintain anxiety disorders.

the primary goals of our 3-year, 2-phase project are to develop aim for primary care linkage and assess its feasibility and acceptability. this protocol description only pertains to phase 2 (randomized controlled trial). 42 primary care patients with primary generalized anxiety disorder, social anxiety disorder, and/or panic disorder (with or without agoraphobia) will be randomly assigned to the aim treatment or to a symptom tracking control group. full assessments will occur pre- and post-treatment and 3-months follow-up. a mid-treatment assessment will include measures of cognitive biases and the primary outcome. weekly measures of anxiety and depression will be collected, as will feedback from patients and pcps about the research and delivery procedures.

Eligibility criteria:
inclusion criteria: study site patient age ≥18 primary diagnosis of generalized anxiety disorder (gad), social phobia (sp), and/or panic disorder with or without agoraphobia (pd/a) at least moderate anxiety severity (gad-7 score \> 10) english-speaking if on psychopharmacotherapy, stable dose for 3 months; to minimize learning effects, patients taking benzodiazepines will complete aim prior to their first dose of the day no current psychotherapy no current severe psychiatric symptoms requiring immediate attention (e.g., imminent suicidality, psychosis)
defining an exposure target for weekly paclitaxel infusion in breast cancer patients

Conditions: Breast Cancer

Summary: the purpose of this prospective observational study is to understand the relationship between paclitaxel exposure and development of peripheral neuropathy during treatment.

paclitaxel is a chemotherapeutic agent commonly used in various tumor types. paclitaxel efficacy and toxicity are "dose-dependent" meaning that increasing the dose increases treatment efficacy and occurrence of toxicity. when used in the weekly 1-hour infusion regimen paclitaxel is commonly associated with treatment-limiting sensory peripheral neuropathy. at the current standard dose of 80 mg/m2 approximately 20-25% of patients experience treatment-limiting neuropathy. drug exposure, not dose, determines treatment efficacy and neuropathy development. when treated with standard doses there is substantial variability in drug exposure meaning some patients are receiving less efficacious treatment than optimal. at this time we do not monitor a patient's exposure because the optimal exposure level has not been defined. the purpose of this study is to prospectively enroll patients for systematic collection of exposure and neuropathy data in order to characterize this relationship. once the relationship between cumulative exposure and neuropathy has been characterized, this model will be used to define an exposure target in future prospective exposure-guided dose-adjustment trials.

Eligibility criteria:
inclusion criteria: * diagnosis of invasive breast cancer * systemic treatment with paclitaxel for curative intent (neoadjuvant, adjuvant, or oligometastatic disease per pi discretion) * 80 mg/m2 1-hour infusions weekly for up to 12 weeks * female sex -\>18 years old * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * any prior or concurrent treatment with neurotoxic chemotherapy including any taxane, vinca alkaloid, platinum, bortezomib, or thalidomide. note that concurrent biologic treatment with trastuzumab/pertuzumab for her2+ patients or prior treatment with adriamycin/cyclophosphamide are not reasons for exclusion. * distant metastatic disease * concurrent treatment with duloxetine or enrollment on clinical study of neuroprotective agent * history of allergic reaction to paclitaxel or cremophor el * current signs or symptoms of severe peripheral neuropathy * known family history of hereditary peripheral neuropathy or charcot-marie-tooth disease * known current pregnancy